Good morning and welcome to Oncolytics Biotech's Third Quarter 2021 Conference Call. All participants are now in a listen-only mode. There will be a question-and-answer session at the end of the call. Please be advised that this call is being recorded at the company's request.

And I would like to turn the call over to Jon Patton, Director of Investor Relations and Communications. Please go ahead..

Thank you, operator and good morning, everyone. Earlier today, Oncolytics issued a press release providing financial results and corporate updates for the third quarter of 2021. A replay of today's call will be available on the Events & Presentations section of the Oncolytics website approximately two hours after it's completion.

After remarks from company management, we will open the call for Q&A.

As a reminder, various remarks made during this call contain certain forward-looking statements relating to the company's business prospects and the development and commercialization of pelareorep, including statements regarding the company's focus, strategy and objectives, company's belief as to the potential and mode of action of pelareorep as a cancer therapeutic, the design, aims and anticipated benefits of the company's current pending clinical trials, the company's plans and expectations regarding a potential registrational study, the company's plans regarding the expansion of pelareorep's market and business development potential and other statements related to anticipated developments in the company's business.

These statements are based on management's current expectations and beliefs and are subject to a number of factors which involve known and unknown risks, delays, uncertainties and other factors not under the company's current control that may cause actual results, performance or achievements of the company to be materially different from the results, performance or expectations implied by these forward-looking statements.

Many forward-looking statements in which Oncolytics expresses an expectation or belief as to future results, such expectations or beliefs are expressed in good faith and are believed to have a reasonable basis but there can be no assurance that the statement or expectation or belief will be achieved.

These factors include results of current or pending clinical trials, risks associated with intellectual property protection, financial projections, actions by regulatory agencies and those other factors detailed in the company's filings with SEDAR and the SEC.

Oncolytics does not undertake any obligation to update these forward-looking statements except as required by applicable laws. Now, I'll turn the call over to Dr. Matt Coffey, President and Chief Executive Officer of Oncolytics Biotech.

Matt?.

Thanks, Jon and thanks to all who are joining us today to discuss our third quarter corporate update. Now, in addition to Jon, I'm joined by Tom Heineman, our Global Head of Clinical Development and Operations; Andrew de Guttadauro, our Global Head of Business Development; and Kirk Look, our Chief Financial Officer.

These past months were an important period of execution for Oncolytics. We achieved key objectives that advanced pela down a clear path of a registrational breast cancer study, while simultaneously furthering its development as an immunotherapy backbone that can enable the success of a wide range of agents across multiple indications.

One of the most exciting recent highlights from these past months was actually announced earlier today and relates to new biomarker data from the first two cohorts of AWARE-1 breast cancer study.

As a reminder, AWARE-1, together with our ongoing BRACELET-1 trial in f HR+/HER2- breast cancer was designed to achieve three key objectives in order to answer questions that were posed by regulators and partners regarding the survival benefit observed in IND-213, our prior randomized Phase 2 study that showed a near doubling of overall survival with pelareorep in f HR+/HER2- metastatic breast cancer patients.

These objectives were to confirm that pelareorep works through an immunotherapeutic mechanism of action as suggested by the survival benefit in IND-213 which became apparent about 10 months after the start of treatment.

Second, determine the checkpoint inhibitors synergize with pelareorep; and third, determine the changes in peripheral blood T-cell populations could potentially serve as a novel blood-based biomarker to predict patient response to pelareorep therapy.

Now, on our recent earnings call, we walked through data showing that AWARE-1 had accomplished its primary goals and validated our broader clinical strategy by confirming pela's immunological mechanism of action and demonstrating the synergy between pelareorep and checkpoint inhibition.

With the data we are announcing today which Tom will discuss in more detail, we have further support for these earlier conclusions and evidence that changes in peripheral blood T-cell populations may be predictive of patient response to pelareorep.

This is an exciting finding that could potentially improve our chances of success in subsequent studies by allowing us to quickly identify the patients who are most likely to respond to pelareorep therapy.

It also has us well on our way to achieving the last of the three objectives I just laid out which we expect to complete as part of our ongoing BRACELET-1 study.

One important point to emphasize about the AWARE-1 data we have presented to date is that includes all patients in the first two cohorts which evaluates pela with and without checkpoint inhibition in patients with HR+/HER2- breast cancer.

Evaluation of these cohorts was the core objective of AWARE-1 as HR+/HER2- is the breast cancer sub-type we intend to examine in future registrational study. As I alluded to earlier, the data from these cohorts has allowed the site to meet its primary objective which has our lead program advancing down a clear path towards a registrational study.

The last task we need to accomplish before advancing to such a study is the completion of BRACELET-1 which will Tom will discuss shortly. As we look at data for AWARE-1, we have amended the protocol to keep all ongoing and future cohorts focused on evaluating pela in patients with HER2+ breast cancer.

We are thus not proceeding with AWARE-1 triple-negative cohort as we expect to generate an abundance of data in this breast cancer sub-type for our ongoing IRENE trial which evaluates pelareorep in combination with Insight's PD-1 checkpoint inhibitor, retifanlimab in the metastatic setting which is a less common sub-type.

This will allow us to advance our breast cancer program with efficiency while collecting data in each sub-type of the disease.

Beyond our lead program, we continue to strategically leverage collaborations with industry leaders and academia to unlock additional value by executing on the stated milestones in our other clinical trials such as IRENE and GOBLET which also evaluate pela in combination with a checkpoint inhibitor.

Our efforts towards this goal are bolstered by the robust clinical data set demonstrating pela's ability to act as an immunotherapeutic agent that trains immune cells to fight cancer, while simultaneously enabling their success by weakening or reversing the tumor defense mechanisms that drive checkpoint inhibitor resistance.

Taking a broader view, this differentiated and broadly applicable mechanism of action positions pela as a potentially immunotherapy backbone that can be an enabling technology for a range of immuno-oncology agents even before checkpoint inhibitors such as CAR T-cells and biospecific antibodies.

This provides a multiple of opportunities to further expand pela's market and business development potential. In order to efficiently pursue these opportunities, we plan on utilizing a partner strategy. This will allow us to keep our primary internal focus on advancing pelareorep towards a registration in HR+/HER2- metastatic breast cancer.

We believe this strategy represents the best way to maximize the value pelareorep can generate for shareholders and patients, while ensuring we devote the necessary resources to our lead program. This will position the company to minimize risk as we work to efficiently execute on stated clinical objectives.

With that, I'll now hand it off to Tom who've been talking a bit more in detail about our recent data and progress of our clinical programs.

Tom?.

Thanks, Matt and thanks to all those listening on the call today. I'd like to start by first discussing the compelling AWARE-1 biomarker analyses, Matt mentioned, the results of which we announced for the first time today.

These analyses focused on how pelareorep treatment, both with and without a checkpoint inhibitor, drive changes in peripheral blood T-cell populations and how these changes correlate with CelTIL score and tumor-infiltrating CD8+ T-cells, two metrics that are associated with favorable clinical outcomes.

The goal of these analyses was to identify a potential blood-based biomarker that could be used to quickly identify patients most likely to respond to pelareorep, either before therapy or after an initial treatment cycle.

I'm pleased to say that this goal was accomplished and that we've identified potential biomarkers that will be evaluated further in our Phase 2 BRACELET-1 trial. Now, I'll dive into the specifics of the latest data which, as Matt mentioned, include all patients from AWARE-1's first two cohorts.

As a reminder, these cohorts enrolled patients with HR+/HER2- breast cancer. Cohort 1 patients were treated with pelareorep and hormonal therapy, while Cohort 2 patients received the same treatment regimen plus the checkpoint inhibitor atezolizumab.

A pooled analysis across cohorts showed a statistically significant decrease in peripheral blood T-cell diversity post-treatment due to the expansion and generation of new antiviral and anti-tumor T-cell clones. To provide some context on what this means, you can think of T-cell diversity as a measure of population heterogeneity.

At baseline, there are many types of T-cell clones that are represented in about equal numbers, each program to attack a different target when activated. When diversity has decreased, this means a larger proportion of the T-cell population consists of a limited number of clones designed to attack a select number of specific targets.

So, the fact that we are seeing a statistically significant decrease in diversity tells us that pelareorep treatment drives the T-cell population towards anti-tumor and antiviral clones, providing further evidence of pelareorep's ability to train the immune system to fight cancer.

Importantly, our pooled analysis across cohorts also showed a statistically significant association between pre versus post-treatment decreases in peripheral blood T-cell diversity and increased post-treatment CelTIL scores and a statistically significant association between increased peripheral blood T-cell fraction pre-treatment and tumor-infiltrating CD8+ T-cells post-treatment.

Given the association between CelTIL score and tumor-infiltrating CD8+ T-cells with improved clinical outcomes, we believe these are exciting findings.

In addition to our findings from the pooled analyses, comparative analyses of cohort 1 versus Cohort 2 showed that the addition of atezolizumab enhanced pelareorep's ability to generate and expand new antiviral and anti-tumor T-cell clones, that the decrease in pre versus post-treatment changes in peripheral blood T-cell diversity with checkpoint inhibition and Cohort 2 was greater than that seen in Cohort 1 without checkpoint inhibition and a numerical association between decreased post-treatment T-cell diversity in the peripheral blood and treatment induced increases in tumor-infiltrating CD8+ T-cells in cohort 1.

This association reached statistical significance in Cohort 2 with the addition of atezolizumab. Collectively, our latest AWARE-1 data further demonstrate pelareorep's immune-based mechanism of action and its ability to synergize with checkpoint inhibitors.

They also add to the robust data set showing that the study met its primary endpoint and the pelareorep treatment increased CelTIL scores, increased infiltration of CA positive T-cells into tumors, weaken tumor defense mechanisms by reversing immunosuppressive tumor microenvironments and dramatically upregulated PD-L1 expression.

Notably, many of these desirable effects were enhanced by the addition of checkpoint blockade. With these latest, we now have compelling evidence suggesting that changes in peripheral blood T-cell populations are predictive of responses to pelareorep therapy to potentially serve as a basis for a blood-based biomarker in subsequent studies.

This could improve our chances of success by allowing us to select and is most likely to respond to therapy. Looking forward, the AWARE-1 data we announced today provide our lead breast cancer program with further momentum on its clear path towards a registration study.

The next and final major step on this path is the completion of the ongoing BRACELET-1 trial. As a reminder, BRACELET-1 was designed in collaboration with Pfizer and Merck Serono to support the overall clinical benefit observed in the IND-213 study and to investigate the potential of changes in T-cell populations to serve as a clinical biomarker.

Its design is essentially identical to that of IND-213 with two key exceptions. First is exclusively enrolling HR+/HER2- breast cancer patients, the population in which we saw the most pronounced overall survival benefit in IND-213.

And second, it includes an additional study arm to evaluate the safety and efficacy of pelareorep in combination with Pfizer and Merck Serono's anti-PD-L1 checkpoint inhibitor, Bavencio. We are particularly excited about this study arm given the AWARE-1 data showing synergy between pelareorep and anti-PD-L1 therapy.

This suggests that by adding checkpoint inhibition, we may be able to further improve upon the impressive survival benefit observed in IND-213 patients treated only with pelareorep and chemotherapy.

Since dosing its first patient in 2020, my colleagues at Oncolytics and our investigators at PrECOG, the world-renowned organization managing the study, have done an excellent job rapidly advancing the BRACELET-1 study towards completion.

While the surge in COVID cases driven by the delta variant over the summer caused brief disruptions at some clinical sites, our team was able to quickly adapt to keep the trial moving forward.

Thanks to their talent and dedication we were able to maintain momentum in this important program and are on track to finish enrollment of BRACELET-1 either late this year or in the first quarter of next year.

As we mentioned earlier in the call, the completion of BRACELET-1 is the last major step on our path towards a registrational study in breast cancer.

We expect the data we generate from BRACELET-1 together with the data we already have from AWARE-1 to inform the design of this study while simultaneously providing additional insights that will further position us to take advantage of pelareorep's potential across additional cancer populations.

Lastly, before I hand the call off to Andrew, I just wanted to speak briefly about some very interesting preclinical studies that were presented at the international conference on immunotherapy radiotherapy combinations.

These studies evaluated various treatment combinations of pelareorep, radiotherapy and anti-PD-1 therapy in mice with two bilateral tumors, each located under the skin on a different side of the body.

Radiotherapy and/or pelareorep treatment was delivered locally to one tumor denoted the primary tumor, while the second tumor which was denoted the abscopal tumor was not directly exposed to either therapy.

Results from the studies showed that compared to single-agent radiotherapy, the pelareorep radiotherapy combination led to more animal surviving which reads statistical significance when anti-PD-1 therapy was administered systemically.

Additionally, these increases in survival were accompanied by increased infiltration of anticancer T-cells in both the primary and abscopal tumors which is indicative of synergistic immunotherapy effects of the pelareorep, radiotherapy combination.

These compelling findings, together with our prior clinical data and preclinical results showing the pelareorep synergistically combines with agents such as CAR T-cells, biospecific antibodies, PARP inhibitors and CDK 4/6 inhibitors highlight pelareorep's potential as an enabling technology that can enhance the efficacy of a wide range of therapies beyond checkpoint inhibitors.

In order to pursue pelareorep's development in combination with agents beyond checkpoint inhibitors, we plan to utilize a partnership strategy so that we can maintain our focus on our lead breast cancer program and the execution of our ongoing clinical trials.

Now, to speak a bit more about this partnership strategy as well as our broader business development efforts, I'll hand it off to Andrew.

Andrew?.

Thanks, Tom and thanks to all who have joined us on today's call.

Before I elaborate further on Tom's point, I'd like to first discuss some of our work leveraging collaborations with industry leaders to expand pelareorep's potential therapeutic impact by developing it in combination with checkpoint blockade and indications beyond HR+/HER2- breast cancer. This work is embodied by several ongoing trials.

These include our trial with BMS, evaluating pelareorep Opdivo combination therapy multiple myeloma, IRENE which is a Phase 2 study, evaluating pelareorep in combination with Insight's PD-1 checkpoint inhibitor, retifanlimab in metastatic triple-negative breast cancer; and GOBLET, our phase 1/2 trial, evaluating pelareorep in combination with Roche's PD-L1 inhibitor atezolizumab in patients with metastatic pancreatic, metastatic colorectal and advanced renal cancers.

We are very pleased with the progress we've seen in each of these studies. Patient dosing was initiated in GOBLET last week, while IRENE and our multiple myeloma study are on track for interim safety updates by the end of the year.

With each of these trials, we aim to leverage the immunotherapeutic effects pelareorep is demonstrated AWARE-1 and other clinical studies. These effects can reverse to tumor defense mechanisms that limit the efficacy of checkpoint inhibitors.

By doing this, we believe we can address a pressing unmet need and tap into a large commercial opportunity as the checkpoint inhibitor market is expected to reach $55 billion by 2025 despite less than one in five patients responding to these therapies.

The combination of unmet need and the commercial opportunity for agents that can enhance the efficacy of checkpoint inhibitors has driven large pharma's growing interest in this space. This interest bolsters our efforts to execute on our BD strategy as we work towards the goal of securing a global clinical and commercialization partnership.

By engaging large pharma companies in the collaborative trials I just discussed, we are able to take a proven approach in pursuit of this goal as trials such as these have typically preceded past deals.

Shifting gears a bit, I'd like to highlight some recent progress made by Adlai Nortye, our partner who is working to develop and commercialize pelareorep in China, Hong Kong, Macau, Singapore, South Korea and Taiwan.

Our partners at Adlai recently announced that they dosed the first patient of bridging clinical trial, evaluating the safety, tolerability and preliminary efficacy of pelareorep plus paclitaxel combination therapy in Chinese patients with advanced or metastatic breast cancer.

This bridging trial uses a treatment regimen that is similar to that previously evaluated in the pelareorep-paclitaxel cohort in IND-213.

The bridging trial will enroll approximately 15 to 18 patients with the results expected to allow Adlai to include data from our North American IND-213 and BRACELET-1 trial and a future submission to Chinese regulators. This work, therefore, is intended to accelerate pelareorep's clinical development in Adlai's principal jurisdiction.

Pelareorep's advancement in China is significant, as the country has a rapidly growing biopharmaceutical market that is currently the second largest in the world. Breast cancer is the most common cancer among women in China with over 416,000 cases and more than 117,000 deaths reported in 2020.

Through our continued partnership with Adlai we have set ourselves up to capitalize on the significant opportunity represented by this large market, while minimizing risks and clinical costs.

Lastly, before handing it off to Kirk, I'll build on a point Tom made earlier regarding our strategy to develop pelareorep as an enabling technology for therapeutic agents beyond checkpoint inhibitors.

In order to do this, we are aiming to identify high-quality partners that will take the lead on this development pathway and assume the research responsibilities and costs associated with it.

Our efforts here are supported by emerging preclinical data and our clinical results demonstrating pelareorep's ability to reverse immunosuppressive tumor microenvironments and recruit cancer fighting T-cells into tumors.

These have allowed us to foster collaborations with biotechnology companies and academic institutions such as Leiden University, who we're working with to evaluate pelareorep bispecific antibody combinations in preclinical studies.

While we remain interested in these collaborative efforts and the data we expect them to generate, I should once again emphasize that our primary focus remains on our lead breast cancer program and the execution of our stated clinical objectives.

To ensure we maintain this focus, we plan to continue leveraging our relationships with distinguished collaborators such as Roche, Pfizer, Merck Serono, BMS, Incyte and Adlai Nortye as we work to execute on our goals. We're very pleased with the results the strategies produced to date and believe it has is poised for sustained success.

With that, I'll turn the call over to Kirk Look, our CFO, to discuss our financial results for the third quarter.

Kirk?.

Thanks, Andrew and good morning, everyone. It's my pleasure report that Oncolytics continues to remain in a strong financial position as we advance our lead breast cancer program towards a registrational study and execute on additional clinical and corporate objectives.

Our cash and cash equivalents as of September 30, 2021, was $48.1 million compared to $31.2 million as of December 31, 2020. Based on our current projections, we expect our financial runway will extend into the middle of 2023.

Now, our operating expenses for the third quarter of 2021 were $2.9 million compared to $2.5 million in the third quarter of 2020. This change is largely due to a higher non-cash share-based compensation and Investor Relations activities.

Research and development expenses for the third quarter of 2021 were $3.3 million compared to $3.9 million for the same period last year. Now, this change was largely due to lower manufacturing-related expenses as we completed a cGMP production run in the third quarter of 2020.

This was partially offset by higher R&D compensation-related expenses in support of our expanded clinical program and increased research collaboration activities, including CAR T therapy and biospecific antibody.

The net loss for the third quarter of 2021 was $4.9 million compared to $6.7 million in the third quarter of 2020 which included an FX gain of $1.2 million for the third quarter of 2021 compared to a loss of $0.5 million for the third quarter of 2020.

This equated to a net loss of $0.09 per share for the 2021 period and a net loss of $0.16 per share for the 2020 period on a consolidated basis. With that, I'll hand it back to Matt.

Matt?.

Thank you, Kirk. Now, before we move on to Q&A, I'd like to reiterate how impressed I have been by the talent, the dedication and the nimbleness of the Oncolytics team over the past few months.

Since the pandemic continued to evolve with the surge of the delta variant this past summer, they were able to seamlessly adapt and keep our development programs efficiently moving forward.

Thanks to their efforts, we're heading towards 2022 with positive momentum and robust clinical and preclinical data sets that demonstrate pelareorep's vast immunotherapic effect.

By leveraging these effects, we believe we can develop pelareorep as a backbone therapy that will combine synergistically with checkpoint inhibitors and a broad array of additional immuno-oncology units.

As we work towards this goal, we will remain primarily focused on our lead breast cancer program, while selectively engaging partners and collaborators to announce our efforts in other areas. We expect this to allow us to maintain an optimal benefit risk balance and achieve our regular cadence of catalysts.

These include reporting interim safety updates from IRENE and from our multiple myeloma trial evaluating pela in combination with carfilzomib inhibitor later this year as well as the completion of enrollment in BRACELET-1 which is expected in late 2021 or in the first quarter of 2022.

Looking ahead, I remain excited about our prospects as we head towards the end of the year. Our lead program is advancing down a clear path towards a registrational study, while several other clinical and preclinical programs advance in parallel.

We have a strong team that has consistently executed under the ever-evolving circumstances of the pandemic and we are well positioned to generate value for our shareholders as we work towards our ultimate goal of improving the lives of cancer patients. With that, I'd now like to open the lines and take some questions.

Operator?.

[Operator Instructions] And your first question will be from John Newman at Canaccord. Please go ahead..

Hi guys, thanks for taking my questions. Congrats on all the progress here. I just had two this morning.

The first one is, could you describe how you might incorporate the biomarker analysis from AWARE-1 that you discussed today into some of your other ongoing studies? And second question on GOBLET-1, just wondered if you could remind us of the dosing duration here and any potential color you could give us on timing of the clinical data in the future..

So, the data today, just to kind of contextualize it. When we talk about diversity of our T-cell repertoire, really, if you could just imagine an aquarium full of multi colored fish, so you have red fish, blue fish, yellow fish, green fish, white fish, black fish, if they're equally represented, it's pretty diverse.

Like you look into it and it's like, wow, it's a spectrum of what have you. Now, all of a sudden, the red fish population it flows by like a 100 fold, those -- clones of those red fish just amp up the diversity drop and that's really what this data is telling us.

We get a massive increase in the clonality of these red fish that to carry on the illusion, these are our anti-tumor clones. So, the clonality shoots up and the diversity drops.

What this allows us to do with a simple blood draw is we can do a three mill draw at as early as two to three weeks and if we see this drop in diversity and this increase in these new T-cell clones, this is correlating very strongly with positive CelTIL. We've demonstrated it correlates very positively with overall survival in pancreatic cancer.

So what that allows us to do is stratify these patients. So, basically, this is a very easy way to enrich or follow-up on the patients that are deriving benefit. And really, this will be verified with BRACELET but we've now seen this in breast cancer and pancreatic after and it really becomes the focus of the GOBLET study as well.

So what it allows us to do in the clinical testing phase is to run much smaller studies that are much more nimble because we can follow the patients that are having the desired immunological effect. And what's nice about this is the reproducibility of it. We're seeing this across indications in the clinical settings.

We're also seeing it in animal testing. So, this appears to be a very strong effect that is indicative of response in preclinical, clinical and across indications so we're very excited about it.

From a commercial perspective, this is also very nice for the patients, because immunological agents like ours, it often takes -- you don't see dramatic changes in PFS, you see dramatic changes in overall survival. But these patients are dealing with a finite window of opportunity.

So, we can tell as early as two to three weeks if they're deriving the benefit that we're looking for which allows payers to accept agents by tiers much more readily because we can tell which patients are responding and which ones aren't.

And from the patient perspective, if they're not seeing the desired vaccination effect, we can get them off our therapy and on to something else that might be more successful for them, because we really are moving towards a tailored approach to oncology. So, this approach, it will be verified with BRACELET and will form a basis for our Phase 3.

What's also nice about this approach is in pancreatic cancer and again, we'll see more of this in BRACELET, at baseline, if we see very little immunological activity, if there are very few T-cell clones, if there are no predominant loans or no variation in the ratio of these clones, it really just speaks to the fact that they don't have much immunological reserve left because of great statements with chemotherapy and radiotherapy and we know they're poor candidates.

So, we can eliminate those patients onto the clinical setting before we even treat them. So, again, it creates more and more robust clinical data for us and I think dramatically improves our chances of the success in the clinical breast cancer is stuff because it is so heterogenous.

But if we can identify the patients that are likely to respond, it levels the playing field and I think gives us a dramatic improvement in our ability to be successful. Now, for your second question, duration of treatments, I'm going to push Dr. Heineman under the bus. Tom, can you speak to GOBLET a little bit for Dr.

Newman?.

So, yes, so keep in mind that the GOBLET study is a platform study in which we are treating patients with four different types of GI cancers. And so the treating regimens -- the treatment regimens are a little bit different depending on the type of cancer.

So, patients will be treated with either pela -- all patients will be receiving pelareorep and atezolizumab. In a couple of the cohorts, patients, for example, with pancreatic cancer or with third line colorectal cancer will also be receiving standard of care chemotherapy. And so the treatment regimens vary a little bit.

Patients will be receiving pelareorep weekly and atezolizumab according to its normal administration schedule and then chemotherapy is appropriate and they will continue to be treated on the study as long as the investigators believe they are deriving benefit from the treatment..

Okay, great. Thank you..

Sure..

Any further questions, Mr.

Newman?.

No, that's all. Thank you..

Thank you. Your next question will be from Patrick Trucchio at H.C. Wainwright. Please go ahead, Patrick..

Hi, good morning and congrats on all the progress. I have a follow-up question on the potential for a combination of pela plus CAR T.

I'm wondering if there is a preference for moving forward with autologous CAR T-cells or allogeneic CAR T-cells? And secondly, what tumor type or types do you believe would be ideal for this combination of pela plus CAR T? And finally, what's the status of any discussions around our potential collaboration?.

We're actually exploring both autologous and allogeneic CAR T. And the reason for that is, I think, the recent CRISPR data with allogenic looks fantastic. But I think for the next 5 to 10 years, autologous CAR Ts are going to be dominant in this field. So, I think we're running things in parallel.

In terms of targets, we're looking really at the solid tumor market. I think we're speaking with potential partners around hematopoietic indications as well because of the ability of the virus to ramp things up so dramatically in the CAR T setting.

Professor Vile presented data earlier this year that the problem with CAR Ts is they are very short lived. What he demonstrated is loading the CAR T-cells with virus would increase their activity and their persistence.

And importantly, as they started to diminish, you could give a booster of the virus to basically reengage or repopulate those CAR T populations. So that has implications, obviously, in solid and liquid tumors. So, we are really looking at that both.

In terms of our solid tumor targets, the study that we're doing, AWARE-1 really allows us to look at whether the virus is active in breast cancer beyond HR+ disease. So, really, the focus now is looking at HER2+. The work that we did with biospecifics with Leiden University really pointed to the fact that targeting HER2 was a very good area for us.

So, I think not only beyond the CAR T, I think you will likely see us move into HER2+ biospecific approach with the CAR Ts. In terms of our discussions, we have active collaborations with multiple parties in the CAR T space. We're looking to get additional information out in the form of a manuscript here in the very short term.

But it's an area we're very excited about. Because, again, what AWARE and BRACELET-1 are teaching us is the virus is a very good immune adjuvant. It is very good at expanding T-cell population. It is very good at recruiting them to solid tumors.

So, I think you can see us -- the collaborations we're looking at now have a strong emphasis on breast cancer, gastric cancer and non-small cell lung which are, I think, areas of interest for everyone in terms of the CAR T space.

Back to your other question, we are doing autologous and allograft but I think ultimately, the autologous will be replaced just because if you can get an off the shelf CAR T that's applicable for everyone after you fix the HLA, I think it becomes very attractive because it basically becomes just a standardized immune-based assay.

But I don't think they're there yet. We've talked with KOLs in the area. They're suggesting we're probably looking at a 5 to 10-year horizon for that to eclipse the autologous but we do want to get our foot in the door. We want to capture some IP. We want to, I mean, it's the gold rush right now.

We want to make sure that we've staked out our land and have a strong presence in the area. So, we are very active in this space. And as I said, we're collaborating with multiple partners at this point and numerous academic groups..

That's helpful. Thank you very much..

Thank you..

Thank you. And at this time, I would like to turn the call back over to Dr. Coffey. Please go ahead, sir..

I just wanted to thank everyone for their time and attention. We're very excited about what we're seeing in the clinic. We're very excited about our partnership with Adlai Nortye now that they've taken our results and have move them into one of the fastest growing oncology markets. We're very pleased with the GOBLET study.

It hit the ground running, like you wouldn't believe. We're approaching the end of BRACELET-1 which will give us a readout next year, final data on AWARE-1. The AWARE-1 data, I think, exceeded our expectations in terms of the biomarker, the ability to demonstrate that it is killing cell through an immunological mechanism.

So, we're looking forward to the next 12 months and we're very excited about keeping everyone up-to-date with the progress as it becomes available. [Call ends abruptly].